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FDA Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19.  The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission

Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against Intentional AdulterationFDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft Guidance that FDA issued in March 2019 which shares the same title.[1]  Once finalized, these guidance documents will together serve to help covered companies comply with

Assembly Bill 228 is a promising piece of legislation that could soon bring an end to California’s prohibition on adding hemp-derived CBD to foods, beverages, and cosmetics.  The bill, in its current form, would add two provisions to the California Health and Safety Code clarifying that food, beverages, and cosmetics are “not adulterated by the

The FDA and FTC jointly issued warning letters to three companies selling CBD products online. The letters allege violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and the Federal Trade Commission Act (“FTCA”). Although this is the first time the FDA and FTC have issued joint warning letters relating to CBD, the FDA

The National Milk Producers Federation (NMPF) yesterday submitted a citizen petition to FDA related to the use of dairy terms such as “milk,” “yogurt,” “cheese,” “ice cream” and “butter” in the statements of identity for non-dairy plant-based substitutes. The petition argues that the use of these standardized dairy terms to name non-dairy foods falls short

The U.S. and other companies that export foods, additives, colorings, etc. to the European Union (EU) should take notice: new legislation applicable to the agri-food industry is being billed as one of the world’s “most transparent” laws raising potential concerns about protecting proprietary information from competitors.  Controversy surrounding the use of genetically modified organisms and

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to provide the public with an opportunity to offer feedback related to the production of foods using animal cell culture technology.  Stakeholders will also have the opportunity to submit written comments until

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered.

The proposed

“Drawback” is U.S. Customs program that allows importers to get their duty payments refunded by Customs if they export the same or a similar product.  There are lots of permutations and it’s quite a bit of “paperwork” to qualify, but the upside is significant.

Under the recently enacted Trade Facilitation and Trade Enforcement Act (TFTEA),